A study of GSK1278863 in the treatment of anaemia in non dialysis.

• Research type

  Research Study

• Full title

  A 24-week, Phase 2B, randomized, active-controlled, parallel-group, multi-center study to evaluate the safety and efficacy of GSK1278863 in subjects with anemia associated with chronic kidney disease who are not on dialysis.

• IRAS ID

  140466

• Contact name

  Sandip Mitra

• Contact email

  sandip.mitra@cmft.nhs.uk

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2013-002681-39

• Research summary

  The purpose of this study is to test the safety and efficacy (how well a medicine works) of GSK1278863 compared to Erythropoietin (EPO) in treating anaemia of chronic kidney disease (CKD). Anaemia is a condition where the amount of haemoglobin (protein in blood that carries oxygen) is below normal level or there are fewer red blood cells than normal. Subjects not on dialysis will be eligible to participate.
  Subjects stay in the study for 32 weeks with a 4 week screening (monitoring) part, 24 weeks treatment part and then a follow up visit 4 weeks after finishing treatment. Suitable subjects will receive either GSK1278863 or EPO once daily. Neither the patient nor their doctor can choose which treatment is given and it will depend on whether or not they are currently taking EPO to treat anaemia or not.
  Subjects not taking EPO have a 3 in 4 chance of getting GSK1278863 at different doses and a 1 in 4 chance of receiving EPO. Subjects taking EPO have an equal chance of receiving GSK1278863 or continuing on current EPO. Subjects will know which group they are in (because GSK1278863 is a tablet and EPO is an injection) but not the dose.
  Doses may be adjusted if needed until study end for all subjects.
  Subjects will attend the clinic for visits every 4 weeks and there are 3 eye exams / echocardiograms (scans which test how your heart pumps blood) which will be done at separate clinics in the hospital.
  Tests/procedures include
  • Physical examination & medical history, heart monitoring
  • Various blood tests (including pregnancy tests for women who can become pregnant)
  • Pharmacokinetic blood tests (to measure the amount of study drug in the blood)
  • Vital signs: weight, height, blood pressure and pulse
  • eye exams and echocardiograms
  • Subject questionnaires

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  13/NW/0793

• Date of REC Opinion

  27 Nov 2013

• REC opinion

  Favourable Opinion